Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-plantar Erythrodysesthesia (Study P04085)(COMPLETED)

March 26, 2015 updated by: Merck Sharp & Dohme LLC

Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-plantar Erythrodysesthesia (PPE).

The purpose of this study is to evaluate the safety and tolerability of Caelyx in women with advanced ovarian cancer, focusing on infusion reactions and palmar-plantar erythrodysesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This observational program is aimed at gaining tolerability and safety data with the routine use of Caelyx in its labelled indication in ovarian cancer, focusing on infusion reaction and PPE.

Data will be raised about the premedication routinely used for the prevention of side effects caused by Caelyx. Premedications for infusion reactions include corticosteroids, serotonin 3 (5HT3) antagonists, histamine 1 (H1) blockers, and histamine 2 (H2) blockers. Premedications for PPE include oral dexamethasone and vitamin B6.

The management of infusion reactions and PPE will be recorded. A detailed record of the medical history may reveal patient groups at a higher risk of experiencing these side effects.

Study Type

Observational

Enrollment (Actual)

224

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with advanced ovarian cancer with:

previous platin/taxane therapy and

documented measurable and/or evaluable advanced or metastatic cancer by radiological imaging or increase of serum cancer antigen 125 (CA 125) according to Rustin et al.

Description

Inclusion Criteria:

  • Women with advanced ovarian cancer with:

    • previous platin/taxane therapy and documented measureable and/or evaluable advanced or metastatic cancer by radiological imaging or increase of serum cancer antigen 125 (CA 125) according to Rustin et al.

Exclusion Criteria:

  • Patients that are not treated according to the Austrian Summary of Product Characteristics (SPC)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Women with advanced ovarian cancer
Drug: Caelyx (Pegylated Lyposomal Doxorubicin)
Pegylated Lyposomal Doxorubicin, 50 mg/m2 every 4 weeks for 6 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE)
Time Frame: The observational program was conducted over a period of 2 years

Definitions in assessment of adverse event severity:

Mild: awareness of sign, symptom, or event, but easily

tolerated.

Moderate: discomfort enough to cause interference with usual

activity and may warrant intervention.

Severe: incapacitating with inability to do usual activities or

significantly affects clinical status, and warrants

intervention.
The observational program was conducted over a period of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

August 26, 2008

First Submitted That Met QC Criteria

August 27, 2008

First Posted (ESTIMATE)

August 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 15, 2015

Last Update Submitted That Met QC Criteria

March 26, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P04085

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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